Jain Shikha, Majumdar Abha
Centre of IVF and Human Reproduction, Sir Ganga Ram Hospital, New Delhi, India.
J Hum Reprod Sci. 2016 Jul-Sep;9(3):151-158. doi: 10.4103/0974-1208.192053.
The objective of the study is to evaluate the efficacy of gonadotropin-releasing hormone (GnRH) antagonist in improving clinical pregnancy rate in gonadotropin-stimulated intrauterine insemination (IUI) cycles in patients of unexplained infertility.
This was a prospective, randomized case-controlled study.
The study was conducted in the infertility clinic of a tertiary care center.
Four hundred twenty-seven women undergoing IUI following controlled ovarian stimulation with gonadotropins (recombinant follicle-stimulating hormone [r-FSH] 75 IU/day) were randomly divided into two groups. Women in Group I received GnRH antagonist (Cetrorelix 0.25 mg/day) in a multiple dose flexible protocol. Women in Group II received r-FSH alone. Ovulatory trigger was given with human chorionic gonadotropin 5000 IU when dominant follicle was ≥18 mm. IUI was performed within 44-48 h. Both groups received similar luteal phase support. Primary outcome measure was clinical pregnancy rate. The trial was powered to detect an absolute increase in clinical pregnancy rate by 13% from an assumed 20% clinical pregnancy rate in the control group, with an alpha error level of 0.05 and a beta error level of 0.20.
Clinical pregnancy rate in Groups I and II was 27.6% ( = 56) and 26.5% ( = 54), respectively (P=0.800). Ongoing pregnancy and multiple pregnancy rates were likewise similar between the groups.
Addition of GnRH antagonist to gonadotropin-stimulated IUI cycles results in no significant difference in clinical pregnancy rate.
本研究的目的是评估促性腺激素释放激素(GnRH)拮抗剂在改善不明原因不孕症患者接受促性腺激素刺激的宫腔内人工授精(IUI)周期临床妊娠率方面的疗效。
这是一项前瞻性、随机病例对照研究。
该研究在一家三级医疗中心的不孕不育诊所进行。
427名接受促性腺激素(重组促卵泡生成素[r-FSH]75IU/天)控制性卵巢刺激后进行IUI的女性被随机分为两组。第一组女性采用多剂量灵活方案接受GnRH拮抗剂(西曲瑞克0.25mg/天)。第二组女性仅接受r-FSH。当优势卵泡≥18mm时,用人绒毛膜促性腺激素5000IU进行排卵触发。在44-48小时内进行IUI。两组均接受相似的黄体期支持。主要结局指标是临床妊娠率。该试验的设计旨在检测临床妊娠率从对照组假定的20%绝对增加13%,α错误水平为0.05,β错误水平为0.20。
第一组和第二组的临床妊娠率分别为27.6%(n = 56)和26.5%(n = 54)(P = 0.800)。两组的持续妊娠率和多胎妊娠率同样相似。
在促性腺激素刺激的IUI周期中添加GnRH拮抗剂,临床妊娠率无显著差异。